One reason that the minutes are sought for the PACE (Pacing, Graded Activity, and Cognitive Behaviour Therapy—a Randomised Evaluation) trial, which looked at the effectiveness of treatments for chronic fatigue syndrome, is to find out why outcome measures were changed.1 None of the three primary outcomes were reported as in the protocol.2 The recovery criteria in the protocol were very different from what were reported on.2 3

Non-pharmacological therapies are less well regulated than pharmacological ones. For example, there is no equivalent to the yellow card system for adverse events seen with these therapies, so trial reporting becomes more important. Reporting of harms in trials of cognitive behavioural therapy and graded exercise therapy for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) has generally been poor.4 Harms reporting in the PACE trial was improved but problems still remain.4 5

Outside of trials, people with ME/CFS have reported being made more ill by such interventions, but this has largely been ignored,4 which can make people frustrated.

This was an important trial: £5m (€6m; $8m) of taxpayers’ money was invested in it, and it was meant to be the definitive trial. It’s understandable that people want to get as much information from the trial as possible.

Notes
Cite this as: BMJ 2013;347:f5731

Footnotes
Competing interests: TK works in a voluntary capacity for the Irish ME/CFS Association.

References
1. Dyer C. College was right not to disclose deliberations about chronic fatigue treatment trial, tribunal rules. BMJ2013;347:f5355. (30 August.)FREE Full Text

I struggle to see the logic here,1 mainly because I can’t think what would be minuted in a professionally conducted meeting that could not be shared later, once the usual conditions about third party information and data still being prepared for publication have been applied. The debate might move on with some specific, even if fictitious, examples.

Most people are (rightly) deeply suspicious about non-specific appeals to academic freedom or sensitivity of information as an explanation for opacity in public life.

Notes

Cite this as: BMJ 2013;347:f5740

Footnotes

Competing interests: None declared.

References

Dyer C. College was right not to disclose deliberations about chronic fatigue treatment trial, tribunal rules. BMJ2013;347:f5355. (30 August.)
FREE Full Text

The PACE boys and girls have to realise that CBT for exercise avoidance + exercise is unlikely to help/may harm:-
a) those with genuine psychosomatic illness - other than fear of exercise, of course. They will need good psychiatric treatment.
b) those with psycho-behavioural physiological syndromes such as burnout, adrenal burnout, enzyme breakdown under stress, unless accompanied by corrrect physiological treatment - physiological dose hormones , vits, mins etc.
c) those with severe oxidative-nitrosative probs, Rituximab responsive B cell probs,etc. any more than CBT/GET would help lupus or MS or Sjogrens etc etc
d) those with ongoing infection, whether causing actual M Encephalomyelitis, M encephalopathy, dorsal root ganglionitis, or other mimicking infections such as Lymes, Toxoplasmosis, candida etc.
e) those who have been put in the waste basket when they have got entirely different problems such as sleep apnoea, but have been dismissed on the grounds that they must not be encouraged to believe they are ill.

Normal medicine tests and treats appropriately. CBT/GET is still rooted int he gian FIB that we have a false belief problem.

I don't suppose anyone has made the simple observation that depending entirely on self-reports for primary measures is a questionable practice when objective measures are possible, and the goal of therapy is to change illness beliefs, biasing self-reports. Is there any way such a study could fail? Why fund a study that can't fail?

I don't suppose anyone has made the simple observation that depending entirely on self-reports for primary measures is a questionable practice when objective measures are possible, and the goal of therapy is to change illness beliefs, biasing self-reports. Is there any way such a study could fail? Why fund a study that can't fail?

Click to expand...

Anyone can post responses on the BMJ site if so inclined. I think this could be a useful point to make.

Responses don't have to be long or referenced either e.g. http://www.bmj.com/content/347/bmj.f5355/rr/659993 (although if one wants to get published in the print journal, it is best to take some time; but a lot of people are likely happy enough to just get it up on the BMJ site - any response that goes up will have its own link so can be referenced in the future).

I'm not sure about that - but somebody else has pointed out how ridiculous it is to rely on the "patients' subjective opinions" regarding feeling a little bit better on questionaires, when the whole point of the BPS theory is that the patients have "false illness beliefs" in the first place.